Gestational AgePhase 4NCT00813657
Resistance Exercise Training During Pregnancy: a Randomized Controlled Trial
A Phase 4 study testing Exercise in people with Gestational Age and Birth Weight, run by Universidad Politecnica de Madrid.
Trial summary
The investigators investigated the effects of a supervised maternal exercise training program (performed during the 2nd and 3rd trimesters of pregnancy) on maternal-newborn unit health outcomes in a group of previously sedentary healthy women. A matched control group was assessed over the same time period. Read more about this study
- Who is it for?
- Ages 25 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Gestational Age, Birth Weight, Anaemia
- What is being tested?
- Exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- Jan 2000to Mar 2002
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 35 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- sedentary (not exercising >20 minutes on >3 days per week)
- with singleton
- not at high risk for preterm delivery (no more than one previous preterm deliveries)
- women planning to give birth in the same obstetrics hospital department (Hospital Severo Ochoa, Madrid, Spain)
Who cannot join
- not being under medical follow-up throughout the entire pregnancy period were not included in the study
- women having serious medical condition that prevent them from exercising safely
About this study
Official title: Effects of Resistance Exercise Training Program Performed During the 2nd and 3rd Trimesters of Pregnancy on Maternal and Newborn Health
The investigators investigated the effects of a supervised maternal exercise training program (performed during the 2nd and 3rd trimesters of pregnancy) on maternal-newborn unit health outcomes in a group of previously sedentary healthy women. A matched control group was assessed over the same time period. Given the fact that most studies in the field have used aerobic exercises, here the investigators largely focused on very light resistance, toning exercises.
- Being tested
- Exercise
- Medical subject headings
- Birth Weight, Anemia, Diabetes, Gestational
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseBehavioural
Women in the intervention group were enrolled in three sessions/week of individually supervised, resistance exercise training performed over the second and third trimester of pregnancy (in total 26 weeks, ~80 training sessions). Heart rate (HR) was carefully and individually controlled (≤80% of age-predicted maximum HR value, 220-age) through a heart rate monitor during the training sessions. In brief, each session consisted of 35-40 minutes of exercise divided in a light intensity (≤60% maximal heart rate) warm-up period (~8 minutes), followed by toning and very light resistance exercises (~20 minutes) and a light intensity cool-down (~8 minutes) period. Resistance exercises were performed with barbells (≤3kg per exercise) or low-to-medium resistance bands (Therabands).
| Study group | Role | What they receive |
|---|---|---|
| Lifestyle counseling | Experimental | Not described Receives: Behavioral: Exercise |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2008 (estimated)
- Study startJan 2000
- Primary completionMar 2002
- Study completionMar 2002
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gestational AgeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad Politecnica de Madrid
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00813657
- Sponsor's protocol ID
- 01562
- Other IDs
- 01562
- Status last verified
- Dec 2008
- First submitted
- 22 Dec 2008
- Last updated
- 23 Dec 2008
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Resistance Exercise Training Program Performed During the 2nd and 3rd Trimesters of Pregnancy on Maternal and Newborn Health
- ClinicalTrials.gov ID
- NCT00813657
- Acronym / sponsor ID
- 01562
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Universidad Politecnica de MadridUniversity, hospital or other
- Study start
- Jan 2000
- Primary completion
- Mar 2002 (actual)
- Study completion
- Mar 2002 (actual)
- First posted
- 23 Dec 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The investigators investigated the effects of a supervised maternal exercise training program (performed during the 2nd and 3rd trimesters of pregnancy) on maternal-newborn unit health outcomes in a group of previously sedentary healthy women. A matched control group was assessed over the same time period. Given the fact that most studies in the field have used aerobic exercises, here the investigators largely focused on very light resistance, toning exercises.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Lifestyle counseling | Experimental | Behavioral: Exercise |
Who may qualify
- Ages
- 25 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- sedentary (not exercising >20 minutes on >3 days per week)
- with singleton
- not at high risk for preterm delivery (no more than one previous preterm deliveries)
- women planning to give birth in the same obstetrics hospital department (Hospital Severo Ochoa, Madrid, Spain)
Key exclusion criteria (2 listed)
- not being under medical follow-up throughout the entire pregnancy period were not included in the study
- women having serious medical condition that prevent them from exercising safely
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ExerciseWomen in the intervention group were enrolled in three sessions/week of individually supervised, resistance exercise training performed over the second and third trimester of pregnancy (in total 26 weeks, ~80 training sessions). Heart rate (HR) was carefully and individually controlled (≤80% of age-predicted maximum HR value, 220-age) through a heart rate monitor during the training sessions. In brief, each session consisted of 35-40 minutes of exercise divided in a light intensity (≤60% maximal heart rate) warm-up period (~8 minutes), followed by toning and very light resistance exercises (~20 minutes) and a light intensity cool-down (~8 minutes) period. Resistance exercises were performed with barbells (≤3kg per exercise) or low-to-medium resistance bands (Therabands). | Behavioural | Lifestyle counseling |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Dec 2008.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Exercise in people with Gestational Age and Birth Weight, run by Universidad Politecnica de Madrid.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Dec 2008. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Dec 2008.